Tag Archives: HIRT

One of the good things about research that has its own issues, is that there is lots of scope to learn from the things about it that are good, as well as those that aren’t so great. The nice thing about ongoing comment is it gives even more chances to explain why a researcher might make certain choices along the way. Every question in research has more than one way of approaching some answers. Dr Alan Garner returns to provide even more background on this particular study, which has already generated some interesting conversation and a follow-up post.

It’s an excellent thing to be able to keep having discussion around the challenges related to both conducting and interpreting a trial. These things always bring up so many valuable questions, which deserve a response. So this is not going to be quick, but I hope you’ll have a read.

Lots of things changed between the time this trial was designed and now. Standards of care change. Systems, processes and governance models change. Indeed, in this trial standard care changed underneath us. We completed the protocol and gained ethical and scientific committee approval for this study during 2003.

The world was a different place then – at the start of 2003 George W Bush was US President and Saddam Hussein was still running Iraq. There is no keener instrument in medicine than the retrospectoscope particularly when focused 12 years back. Would I have done things differently if I knew then what I knew now – absolutely. Does the trial have hairs? Looks like a yak to me and I don’t think we are pretending otherwise.

Asking Questions

Did we ask the right question? The question was pragmatic. Add a doctor and with them comes a package of critical care interventions that were not routinely otherwise available in our standard EMS system. A number of cohort studies had previously looked at exactly this question and more studies have asked it since. Even papers published this month have examined this question although the issue often overlaps with HEMS as that is how the doctors are frequently deployed.

I might segue slightly to address dp’s question as well which overlaps here. Is it the procedures that the team performs or the person performing the procedures that matter? Dp suggests that a better study design would be to have them all use the same protocols then we compare doctors with non-doctors. Such a randomised trial has actually been done although it is a long time ago now – 1987. It is one of the classic Baxt and Moody papers and was published in JAMA.

Patients were randomly assigned to a helicopter staffed by a flight nurse/paramedic or a flight nurse/emergency physician. The flight nurse and emergency physicians could perform the same procedures under the same protocols including intubation, chest tubes, surgical airways and pericardiocentesis. By TRISS methodology there was lower mortality in the group that included the doctor and the suggestion was this might be related to how they judged the necessity for intervention, rather than technical skill. This study is well worth a read. They note that the outcome difference might have been removed if the nurse/paramedic team was more highly trained but where does this end? We then move into the question of how much training is enough training and this is an area that I think is still in its infancy. Each time you do some research your prompt a whole lot of extra, usually interesting questions.

All That Methods Stuff

Anyway, back to this paper. All analyses presented in this paper were pre-specified in the statistical analysis plan. Although the protocol paper was not published till 2013, the statistical analysis plan (SAP) was finalised by the NHMRC Clinical Trials Centre in August 2010, more than a year prior to follow up of the last recruited patients. Copies of the SAP were then provided to the trial funders and NSW Ambulance at the time it was finalised in 2010. Along the way we have presented data in other settings, mostly at the request of interested parties (such as the Motor Accidents Authority who specifically requested analyses of road trauma cases) and in retrieval reviews. This is why there has been the opportunity for extra public scrutiny by experts like Belinda Gabbe. And public scrutiny is a good thing.

And Standard Treatments?

I’m very happy to provide some reassurance that this study did not rely on junior doctors being put through EMST/ATLS and then sent out to manage severe prehospital trauma patients. Rather the trial protocol states that treatment was according to ATLS principles. In 2003 there was no other external standard of care that we could cite for trauma patient management that was widely and internationally recognised.

The specialists had of course all completed EMST/ATLS but they were also all critical care specialists in active practice in major trauma centres in Sydney with ongoing exposure to severe trauma patients. The average years of prehospital trauma management experience held by this group of doctors at the beginning of the trial was more than 12 years each. They operated to those high level of treatment standards, with regular reviews of management to make sure this was current best practice over the life of a trial that ended up being longer than we hoped.

Other Dimensions of Time

And time wasn’t a friend. Recruitment was indeed slower than planned. This is a common problem in prospective trials. Our estimates of how long it would take to recruit the required sample size were based on a written survey of the major trauma centres in Sydney in 2003 to determine how many unconscious adult blunt trauma patients they were seeing each year. This was reduced to 60% to reflect the fact the trial would recruit for only 12 hours each day (although during the busiest part of the day) and the time needed to recruit was then estimated at 3 years. We in fact planned for 4 years to allow for the fact that patients usually disappear when you go looking for them prospectively. This of course is exactly what happened but to a greater degree than we planned.

I agree it would have been nice to have the results formally published earlier. We did present some results at the ICEM in Dublin in June 2012. It is interesting to note that Lars Wik spoke immediately before me at this conference presenting the results of the CIRC trial on the Autopulse device. This study was finally published online in Resuscitation in March 2014, more than three years from recruitment of their last patient and this trial did not include a six month neurological assessment as HIRT did. Getting RCTs published takes time. Given we did have to perform six month outcome assessments I don’t think we were too far out of the ball park.

To keep you going, here’s a quokka who looks like he’d be up for a chat too. [Via Craig Siczak and unchanged under Creative Commons.]

Randomising in Time Critical Systems

Just to be sure that I really have the right end of the stick on the question of excluding patients after randomisation I ascended the methodology mountain to consult the guru. For those that don’t know Val Gebski he is Professor and Director, Biostatistics and Research Methodology at the NH&MRC Clinical Trials Centre in Sydney. He was our methodology expert from the beginning of planning for the trial.

When I reached the mountain top I had to leave a voice message but Val did eventually get back to me. He tells me excluding patients post randomisation is completely legit as long as they are not excluded on the basis of either treatment received or their outcome. This is why he put it in the study design.

These are essentially patients that you would have excluded prior to randomisation had you been able to assess them properly and of course in our study context that was not possible. The CIRC study that I have already discussed also adopted this approach and excluded patients that did not meet inclusion criteria after enrolment.

Prehospital studies where you have to allocate patients before you have been able to properly assess them are always going to have these kind of difficulties. The alternative for a prehospital RCT would be to wait until you know every element of history that might make you exclude a patient. How many of us have that sort of detail even when we arrive at the hospital?

Extra Details to Help Along the Discussion

The newly met reader might also like to know that the call off rate was about 45% during the trial, not 75%. This is not different to many European systems. If you don’t have a reasonably high call off rate then you will arrive late for many severely injured patients.

And of course the HIRT study didn’t involve “self-tasking”. The system randomised cases on a strict set of dispatch guidelines, not on the feelings of the team on the day. This process was followed for nearly 6 years. There was not a single safety report of even a minor nature during that time. Compliance with the tasking guidelines was audited and found to be very high. Such protocolised tasking isn’t inherently dangerous and I’m not aware of any evidence suggesting it is.

It’s reassuring to know that other systems essentially do the same thing though perhaps with different logistics. For example in London HEMS a member of the clinical crew rotates into the central control room and tasks the helicopter using an agreed set of dispatch criteria. This started in 1990 when it was found that the central control room was so poor at selecting cases, and it resulted in the call off rate falling from 80% to 50%. The tasking is still by a member of the HEMS team, they just happen to be in the central control room for the day rather than sitting by the helicopter.

A more recent study from last year of the London system found that a flight paramedic from the HEMS service interrogating the emergency call was as accurate as a road crew assessing the patient on scene. This mirrors our experience of incorporating callbacks for HIRT.

The great advantage of visualising the ambulance Computer Assisted Dispatch system from the HIRT operations base by weblink was the duty crew could work in parallel in real time to discuss additional safety checks and advise immediately on potential aviation risks that might be a factor.

To consider it another way, why is the model safe if the flight paramedic is sitting at one location screening the calls but dangerous if he is sitting at another? What is the real difference between these models and why is one presumably a safe mature system and the other inherently dangerous?

More Mirrors

I agree that the introduction of the RLTC to mirror the HIRT approach of monitoring screens and activating advanced care resources (with extension to a broader range) was a good thing for rural NSW. However they did activate medical teams into what are very urban areas of Sydney who were neither a long way from a trauma centre nor was there any suggestion they were trapped. Prior to the RLTC the Ambulance dispatch policy for medical teams was specifically circumstances where it would take the patient more than 30 mins to reach a trauma centre due to geography or entrapment. Crossover cases obviously didn’t explain the whole of our frustrating experience of recruitment, but it was one extra hurdle that finally led us to wrap recruitment up.

You can’t bite it all off at once

In a study where you collect lots of data, there’s no publication that will let you cram it all into a single paper. So there are definitely more issues to cover from the data we have. This includes other aspects of patient treatment. So I will be working with the other authors to get it out there. It might just require a little bit of time while we get more bits ready to contribute to the whole picture.

Of course, if you made it to the end of this post, I’m hoping you might just have the patience for that.

More of the operational data from the Head Injury Retrieval Trial has just been published. By luck more than anything else this has occurred within 24 hours of the publication of the main trial results which you can find here.

Some operational data about systems used in the trial has already been published. A key part of HIRT was a dispatch system where the operational crew were able to view screens with case information as they were logged to spot patients who may have severe enough injuries to warrant advanced care. They could then use the available information or call the initiating number for further details. If the available information matched the criteria for consideration of an advanced care team, the randomisation process then swung into action. The whole idea was to streamline the process of activation of an advanced care team to severely injured patients.

A study looking at this dispatch system in the context of identifying severely injured children has already been published here. This study compared the trial case identification system with the Rapid Launch Trauma Coordinator (RLTC) system in NSW. When the trial dispatch system was operating the paediatric trauma system in Sydney performed significantly better than when the trial system was not available. This was a combination of the dispatch system and the rapid response capability of the trial HEMS. The speed and accuracy of dispatch was a key component however.

So what’s this new paper about?

In this new paper we had the opportunity to explore the HIRT data set to look at the times it took various team models to treat patients and get them to the hospital, and then through the ED to CT. The data is unique as far as I know as we had the unusual situation of two physician staffed services operating in parallel sometimes being dispatched to the same patients.

Getting to a CT scanner in a more timely fashion than this was a way of tracking patient progress through their care. [via telegraph.co.uk]First comment is that this appears to confirm some European data that physician teams do not significantly affect prehospital times when compared with paramedics although the intubation rate is much greater. Papers such as that by Franschman from the Netherlands make interesting comparisons with this paper. The Dutch Physician staffed HEMS system closely mirrors the HIRT rapid response system in time intervals (and many other factors too). The fact that we have such similar results half a world apart suggests some generalisability of the data.

So are there some differences?

This study did show some differences between the physician teams in those time markers through the patient pathway. It’s worth making a couple of comments that might help to interpret that data.

This is not about individual performance but about systems. There were doctors and paramedics who worked across both systems. Their times followed the pattern of the system they were operating in on any given day.

If you look in the study discussion, the two physician HEMS systems are quite different. The Greater Sydney Area (GSA) HEMS forms part of the State ambulance helicopter system. It has to be all things to all people all the time. They have a wide range of tasks including interfacility transports, hoisting operations, ECMO and IABP transfers etc and they may potentially be tasked anywhere in NSW and perhaps up to 100nm off the coast. By necessity they are multirole and they have to be able to respond to any of these mission types when the phone rings without any notice.

The rapid response HEMS system that was set up for the trial is not constrained in the same way. It is a specialist service where every mission follows the same basic pattern. This data indicates that it is very, very good at doing one thing. Indeed as far as I am aware the scene times for intubated patients are the fastest achieved for a physician staffed HEMS anywhere in the world, even slightly faster than the published data from the Netherlands. The price of specialisation however is that this service cannot perform the range of tasks that the multirole GSA HEMS undertake.

Put simply the services are not interchangeable. The data indicates that the specialist rapid response model will arrive at patients first compared with the multirole GSA HEMS model anywhere in the greater Sydney area, except at the extreme edges of their operating range where rural bases may be faster, or within a couple of km of the GSA HEMS Sydney base.

The differences also apply to scene times where the HIRT rapid response system had scene times of half that or less observed in the GSA HEMS teams, even when confounders such as entrapment and requirement for intubation were considered. We speculate on some reasons for this such as the relative team sizes for the two operations. There may well be advantages in highly familiar teams. There is certainly some evidence for this in other areas of medicine.

What do we make of this?

Overall however I think specialisation is the key. If we again compare the HIRT rapid response model to the Dutch physician staffed HEMS system the similarities are striking. Like the HIRT system, the Dutch only perform prehospital cases, they only operate within a limited radius of their operating base (including urban areas) and they do not have hoists. Like most European HEMS they have small team sizes. And their times are remarkably similar to that achieved by the HIRT HEMS system in our study. It is all about how the services are structured and their role definition which makes them good at what they do.

There are clear implications for the task allocation system in Sydney from this data.

The current pattern of tasking appears to allocate physician teams primarily on who is closest. This allocation only makes sense if the two teams are interchangeable in capability. This is very clearly not the case. The two systems are quite different. The relative strengths of each service should be taken into account in the dispatch policy so that patients will get the most rapid and most appropriate response possible given their location and clinical condition.

The patient doesn’t care who started out closer. They want the service they need for their situation. The different strengths of the two services should form a complimentary system that ensures the fastest and highest quality care to patients, whether they are on the roadside, already in a smaller hospital, at the base of a cliff or on a ship off the coast.

What about dispatch?

The evidence from this study combined with the previous study on the Sydney paediatric trauma system also indicates that the HIRT case identification system significantly outperformed the RLTC in both speed and accuracy.

The trial case identification system operated for nearly 6 years without a single report of any type of safety incident, even of a minor nature. Once the RLTC came into being in 2007 the RLTC and HIRT systems operated collaboratively to identify severely injured children and ensure a speedy response. When HIRT identified a paediatric case, they checked with RLTC who retained tasking control to ensure that there was no additional information or competing tasks that might affect the dispatch decision. In this way Ambulance retained central control and oversight of the system and a double up of tasking to paediatric patients was averted. This would seem to be the ideal system with patients benefiting from the increased speed and accuracy of the parallel case identification process when the HIRT and RLTC systems were operating together, but Ambulance retaining central control so that competing tasks could be balanced. The HIRT dispatch system was however discontinued in 2011 when the last patient was recruited into the trial.

The practical difficulties of applying this level of sophistication to resource allocation, given the sheer volume and variety of demands on the centralised despatch system, need to be acknowledged. Nevertheless it might be time for a rethink.

There’s always a bit of extra reflection you can’t include in the discussion of a research paper. Dr Alan Garner reflects more on some of the challenges of doing research in prehospital medicine.

The main results of the Head Injury Retrieval Trial have now been published on-line in Emergency Medicine Journal. We have paid the open access fees so that the results are freely available to everyone in the spirit of FOAM. This was an important study that was eagerly awaited by many clinicians around the world.

The summary from my point of view as the chief investigator: an enormous opportunity wasted.

It is now nearly ten years since we commenced recruiting for the trial in May 2005. Significant achievements include obtaining funding for a trial that was ultimately to cost 20 million Australian Dollars to run. I am not aware of another prehospital trial that has come anywhere close to this. Hopefully this is a sign that prehospital care is now seen as worthy of the big research bucks.

In the subsequent ten years world events have helped to drive increasing investment in prehospital trauma research, particularly conflicts in Iraq and Afghanistan and the perception that there were many preventable deaths. The US government has become a big investor in prehospital research that might lower battlefield mortality. The Brits on the other hand typically made some assumptions based on the evidence they had and got on with it. Higher levels of advanced interventions during evacuation as exemplified by the British MERT system in Afghanistan seem to be associated with better outcomes but the evidence is not high quality.

I am the first to acknowledge that randomised trials are inherently difficult when people are shooting at you. Most prehospital care is not quite that stressful but there remain significant barriers to conducting really high quality prehospital research. Taking the evidence you have and getting on with it is a practical approach but it is not a substitute for meticulously designed and executed high quality studies. Such studies often disprove the evidence from lower level studies. We all bemoan the lack of good data in prehospital care and recognise the requirement for better research.

When you’re only left with signals

The Head Injury Retrieval Trial taken in this context really is an opportunity wasted. There is a strong signal in the as-treated analysis of unconscious trauma patients that there is a significant difference in mortality associated with physician prehospital care. The Intention to treat (ITT) analyses was not significant however.

The potential reasons for the lack of difference in the Intention to Treat group is really best appreciated by looking at the difference in intervention rates in Table 2. Both treatment teams (additional physician or paramedic only) could intubate cold so we only report the rate of drug assisted intubation. This was by far the most common physician only intervention, and the one we have been suspecting to make the most difference to head injured patients. When you look at the rates receiving this intervention it was 10-14% in the paramedic only group due to the local ambulance service sending their own physician teams in a good percentage of patients, compared with 49-58% in the treatment group. If this really is the intervention that is going to make the difference, our chances of demonstrating that difference are not great unless the treatment effect is absolutely massive.

When the system you study changes

The Ambulance Service in NSW decided two and half years into the trial that they considered physician treatment to already have sufficient evidence to make it the standard of care. They partially replicated the trial case identification system to enhance identification of patients that they believed would benefit from dispatch of a physician (there’s more detail in the HIRT protocol paper).

This is not the first time that such a thing has happened. In the OPALS study of prehospital advanced life support in Canada in 2004 the original study design was a randomised trial (Callaham). It was however done as a cohort study owing to the belief of paramedics that it was unethical to withhold ALS despite absence of proof of its efficacy. We bemoan the lack of evidence but belief in the efficacy of established models of care make gathering high quality evidence impossible in many EMS systems. NSW has proved to be no exception.

Sydney remains a good place to do this work of course.

Where are we then?

So where does this leave Sydney? I think a quote from Prof Belinda Gabbe best sums up the situation. Prof Gabbe is a trauma researcher from Monash who has published much on the Victorian trauma system and was brought in as an external expert to review the HIRT outcome data during a recent review of the EMS helicopter system in New South Wales. Her comment was:

“As shown by the HIRT study, physician staffed retrieval teams are now an established component of standard care in the Sydney prehospital system. The opportunity to answer the key hypothesis posed by the study in this setting has therefore been lost and recommendation of another trial is not justified. Future trials of HIRT type schemes will therefore need to focus on other settings such as other Australian jurisdictions, where physician staffed retrieval teams are currently not a component of standard care”.

The only jurisdiction in Australia with enough patients to make such a study viable that does not already use physicians routinely is Victoria. Such a study would be particularly interesting as the recent randomised trial of paramedic RSI from that state found absolutely no difference in mortality, the area where the HIRT trial indicates there well may be a difference. Any potential trial funder would want some certainty that history would not repeat itself in the standard care arm however.

In NSW though, the question of whether physician care makes a difference to patient outcome is now a moot point. It is now the standard of care – HIRT has definitively demonstrated this if nothing else. All we can do now is determine the best way of providing that care. We have more to publish from the data set that provides significant insights into this question so watch this space.